Details for New Drug Application (NDA): 216606
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NDA 216606 describes NISOLDIPINE, which is a drug marketed by Amta and Mylan and is included in three NDAs. It is available from one supplier. Additional details are available on the NISOLDIPINE profile page.
The generic ingredient in NISOLDIPINE is nisoldipine. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the nisoldipine profile page.
The generic ingredient in NISOLDIPINE is nisoldipine. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the nisoldipine profile page.
Summary for 216606
| Tradename: | NISOLDIPINE |
| Applicant: | Amta |
| Ingredient: | nisoldipine |
| Patents: | 0 |
Pharmacology for NDA: 216606
| Mechanism of Action | Calcium Channel Antagonists |
| Physiological Effect | Decreased Blood Pressure |
Medical Subject Heading (MeSH) Categories for 216606
Suppliers and Packaging for NDA: 216606
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NISOLDIPINE | nisoldipine | TABLET, EXTENDED RELEASE;ORAL | 216606 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-976 | 23155-976-01 | 1 BOTTLE in 1 CARTON (23155-976-01) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE |
| NISOLDIPINE | nisoldipine | TABLET, EXTENDED RELEASE;ORAL | 216606 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-977 | 23155-977-01 | 1 BOTTLE in 1 CARTON (23155-977-01) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 8.5MG | ||||
| Approval Date: | Apr 10, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 17MG | ||||
| Approval Date: | Dec 12, 2025 | TE: | RLD: | No | |||||
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